Position Summary
The Yu laboratory is seeking a clinical research assistant I to assist with cutting-edge, small-scale trials in personalized medicine. These are studies for individualized therapies (genetically targeted experimental medicines) for children with life-threatening ultra-rare genetic conditions. The clinical research assistant will be responsible for assisting with the day-to-day operations under immediate supervision, including screening, consenting, budget and protocol development and communication. This is an exciting opportunity to work within a multidisciplinary team furthering research and bringing new treatments to rare genetic conditions and is an ideal position for someone who desires to be at the intersection of cutting-edge research and patient care. Experience with human subject clinical trials is a plus. Minimum of a 2-year commitment.

Key Responsibilities

• Assisting with protocol and consent development under supervision, coordinating the activities of daily operations of clinical research studies
• Organizing and scheduling study participants for study visits or procedures
• Communicating schedule of study events with research families and serve as liaison to the families/patients in the research studies, conducted at both on-site and off-site locations, guiding and advising them throughout each phase of the study.
• Assisting the PI during patient visits
• Collecting study specimens at the bedside and operating room and delivering or shipping to appropriate locations
• Maintaining regulatory and subject binders, case report forms, and other study documents
• Writing study submissions to the Internal Review Board (IRB), U.S. Food and Drug Administration (FDA),and Data Safety Monitoring Committee (DSMC), including amendments and reportable events
• Maintaining patient sample organization and inventory
• Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis. May write articles and summaries of studies for submission. May present study results at local and national meetings
• Participates in the training of newly hired research study assistants, as required.
• Performs other miscellaneous administrative duties as assigned or required.

Minimum Qualifications
Education:

• Bachelor’s degree

Experience:

• Strong communication skills to effectively communicate with families/parents/study participants to explain the study, recruit and schedule, and provide them with accurate information.
• Good analytical skills to collect information from diverse sources.
• Well-developed writing skills and the ability to work independently are also needed.
• Experience with human subject clinical trials is a plus.
• Successful candidates will be highly collaborative, passionate about innovative medicine, self-motivated, organized, and have good people skills.
• Minimum of a 2-year commitment required.